[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"IBSA Farmaceutici Italia Srl\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":143},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,43,72,94,117],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100586377","safety-and-efficacy-evaluation-of-sodium-hyaluronate-32mgml-in-improving-facial-skin-dryness-and-dullness-100586377",false,"NCT06914583","Safety and Efficacy Evaluation of Sodium Hyaluronate 32mg\u002Fml in Improving Facial Skin Dryness and Dullness","A Prospective, Multi-center, Randomized, No-treatment Controlled, Evaluator-blinded, Superiority Clinical Trial to Evaluate the Safety and Effectiveness of Sodium Hyaluronate 32 mg\u002Fml for Improvement of Facial Skin Dryness and Dullness","Inclusion Criteria:\n\n1. Age ≥18 years old and ≤65 years old (based on the time of signing the ICF), gender is not restricted;\n2. Skin Fitzpatrick is classified as type II-IV;\n3. Subjects who are seeking temporary improvement of their dry facial skin and dull complexion. The investigator has assessed the subjects are suitable for receiving injectable treatment to improve these conditions;\n4. Subjects who have agreed not to use any other medical cosmetic treatments related to the study during the study period;\n5. Subjects who voluntarily sign a written informed consent form, and able to comprehend the full nature and the purpose of the investigation, including possible risks and side effects, and subjects able to cooperate with the investigator and to comply with the requirements of the entire investigation (including ability to attend all the planned investigation visits according to the time limits), based on investigator's judgement.\n\nExclusion Criteria:\n\n1. Known allergy to hyaluronic acid or any component of this product;\n2. Known history of severe allergies;\n3. Known history of severe autoimmune disease;\n4. Subjects with episode of herpes cutis;\n5. Subjects with cicatricial diathesis;\n6. Facial area has unknown injection substances;\n7. Have received any permanent or semi-permanent fillers at the facial area (e.g., calcium hydroxyapatite, poly-L-lactic acid, polymethyl methacrylate, silicones, expanded polytetrafluoroethylene (ePTFE), polycaprolactone, etc.), autologous fat, face lift (including thread lifts), etc., or plan to receive any of the above treatments during the investigation;\n8. Have received temporary dermal filler treatment (e.g., cross-linked hyaluronic acid, collagen) at the facial area within the 12 months prior to enrolment, or plan to receive any of the above treatments during the investigation;\n9. Have received botulinum toxin injection, mesotherapy, or facial cosmetic procedures (e.g., facial liposuction, cosmetic surgery, face slimming, photo modulation therapy, intense pulsed light, radiofrequency, non-cross-linked hyaluronic acid injection (except for mesotherapy), dermabrasion, laser or chemical peels or other ablation procedures, etc.) at facial area within 6 months prior to enrolment, or plan to receive any of the above treatments during the investigation;\n10. Have received sodium hyaluronate compound solution injection (mesotherapy, etc) at facial area within 3 months prior to enrolment,\n11. Facial area has active or progressive skin infection (including viral, bacterial, fungal);\n12. Facial area has skin granuloma;\n13. Facial area has active or progressive skin diseases or with isomorphic reactions such as acute eczema, flat warts, lichen planus, psoriasis vulgaris, etc.;\n14. Facial area has malignant tumors or skin tumors of unknown nature;\n15. Subjects who work outdoors for a long time or need to be exposed to sunlight after surgery;\n16. Patients with excessive expectations for treatment effects;\n17. Subjects with coagulation dysfunction or other systemic diseases;\n18. Subjects undergoing chemotherapy\u002Fradiotherapy;\n19. Subjects with mental illness or emotional instability;\n20. Subjects who had received any thrombolytic agents, anticoagulants or antiplatelet drugs within 2 weeks before enrolment;\n21. Subjects who are pregnant or planned to become pregnant during the investigation period, or breastfeeding;\n22. Subject who participated in other clinical investigation within 1 month prior to enrolment in this investigation, or currently participating in other clinical investigation;\n23. The investigator considers that the subject is not suitable to participate in this clinical investigation.",true,"ALL","18 Years","65 Years",{"count":21,"type":22},500,"ESTIMATED","INTERVENTIONAL",[25],"NA","The aim of the study is to evaluate the safety and efficacy of sodium hyaluronate 32 mg\u002Fml in improving facial skin dryness and dullness. Subjects are randomized to the treatment group or to the control group. Only subjects in the treatment group are treated by intradermal injection.",[28,29],"Facial Dryness","Facial Dullness","RECRUITING","2025-03-31",{"date":33,"type":34},"2025-04-06","ACTUAL",{"date":36,"type":34},"2025-02-19",{"date":38,"type":22},"2026-02",{"name":40,"class":41},"IBSA Farmaceutici Italia Srl","INDUSTRY",6,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":50,"enrollmentInfo":51,"targetDuration":4,"studyType":23,"phases":53,"briefSummary":54,"conditions":55,"keywords":58,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":71},"100578374","evaluation-of-the-effects-of-two-dietary-supplement-formulations-on-the-lipid-profile-in-mild-hypercholesterolemia-100578374","NCT06810466","Evaluation of the Effects of Two Dietary Supplement Formulations on the Lipid Profile in Mild Hypercholesterolemia","A Single-blind, Parallel-group, Randomized, Placebo-controlled Clinical Trial, to Evaluate the Effects of Two Different Formulations of a Dietary Supplement on the Lipid Profile in Subjects with Mild Hypercholesterolemia","Inclusion Criteria:\n\n* Prevention of cardiovascular disease\n* Low cardiovascular risk (\\\u003C 5%)\n* Sub-optimal serum levels of LDL-C (130-136 mg\u002Fdl; 3.37-4.14 mmol\u002Fl) and\u002For non-HDL-C (160-190 mg\u002Fdl; 4.14-4.92 mmol\u002Fl) at T-2\n* Signature of informed consent.\n\nExclusion Criteria:\n\n* Patients with cardiovascular disease (in secondary prevention) or at risk of cardiovascular disease after 10 years (cardiovascular risk \\>\u002F= 5)\n* diabetes mellitus\n* Taking hypolipemiants, supplements or drugs that may involve lipid metabolism\n* Hypertension treatment not stabilized for at least 3 months\n* History of ongoing kidney, thyroid, gastrointestinal, muscle or liver disease\n* Any medical-surgical treatment that may limit adherence to the study protocol\n* Pregnant and\u002For breastfeeding women","69 Years",{"count":52,"type":22},99,[25],"A single-center, randomized, parallel-group, double-blind, placebo-controlled clinical study followed by an open-label phase to evaluate the effects of a new formulation of a supplement on lipid profile in subjects with mild hypercholesterolemia who are non-responsive to the Mediterranean diet.\n\nThe study population consists of 99 subjects with mild hypercholesterolemia who are non-responsive to the Mediterranean diet. The participants will be divided into three groups:\n\nGroup A: Test Product A (study product) Group B: Test Product B (comparative product) Placebo group: placebo\n\nThe following visits are scheduled during the study:\n\nT-2 (day -35) - Screening visit, 5 weeks before T0 T-1 (day -28) - Enrollment visit, 4 weeks before T0 T0 (day 0) - Randomization visit, baseline T1 (day 56) - Interim visit, 8 weeks after T0 T2 (day 112) - Final visit, 16 weeks after T0 After the first 8 weeks of the study (double-blind), all three groups will continue with only Product A for an additional 8 weeks. This experimental design aims to highlight whether any differences between Test Product A and Test Product B observed during the first 8 weeks can be minimized when both arms receive the same treatment. Additionally, the effect of Product A will be observed at 8 and 16 weeks, thus providing efficacy data over a longer treatment period. This may also provide insights into the potential achievement of a plateau. Regarding the placebo group, it will be possible to distinguish the effect of the diet alone from the combined effect of the diet and supplementation with Test Product A.",[56,57],"Hypercholesterolemia and Hyperlipidemia","Supplementation",[59,60,61,62],"mild hypercholesterolemia","supplement","lipid profile","dietary supplement","2025-01-30",{"date":65,"type":34},"2025-02-05",{"date":67,"type":34},"2024-12-17",{"date":69,"type":22},"2026-01",{"name":40,"class":41},1,{"id":73,"slug":74,"hasResults":11,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":4,"eligibilityCriteria":78,"healthyVolunteers":16,"sex":17,"minAge":79,"maxAge":19,"enrollmentInfo":80,"targetDuration":4,"studyType":23,"phases":82,"briefSummary":83,"conditions":84,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":71},"100511200","evaluation-of-safety-and-tolerability-of-salvia-haenkei-extract-as-a-dietary-supplement-ingredient-100511200","NCT05936346","Evaluation of Safety and Tolerability of Salvia Haenkei Extract As a Dietary Supplement Ingredient","Evaluation of Safety and Tolerability of Salvia Haenkei Extract As a Dietary Supplement Ingredient in a Healthy Population: a Randomized, Open Label, Parallel-arm, Two-dose Study","Inclusion Criteria:\n\n* Informed consent as documented by signature\n* Male or female\n* Age 55-65 years, inclusive\n* In good general health as evidenced by medical history and current health status\n* Willingness to maintain dietary and sports habits as of baseline\n* Willingness and ability to comply with the requirements of the study\n\nExclusion Criteria:\n\n* Body Mass Index \\\u003C 18.5 or ≥ 30\n* Difficulty in swallowing (dysphagia)\n* Known allergy or sensitivity to any ingredient of the study intervention\n* Any medical condition or clinically significant abnormalities in laboratory values (hematology, blood chemistry, urinalysis) at screening which in the judgment of the Investigator makes the subject unsuitable for the study\n* Planned or anticipated major surgical procedure during the subject's participation in this study\n* Inability or contraindications to undergo the study intervention\n* Inability to follow the procedures of the study (e.g. due to language problems, psychological disorders, dementia, etc.)\n* Use of any new vitamins, herbal or dietary supplements, functional foods and sports drink, of any kind, liable or presented as liable to enhance physical performances within one month prior to the start and during the study","55 Years",{"count":81,"type":22},50,[25],"Evalution of the safety and tolerability of the oral administration of Salvia haenkei in a healthy population.",[85],"Aging","2025-01-21",{"date":88,"type":34},"2025-01-23",{"date":90,"type":34},"2023-07-17",{"date":92,"type":22},"2025-04-30",{"name":40,"class":41},{"id":95,"slug":96,"hasResults":11,"nctId":97,"briefTitle":98,"officialTitle":99,"acronym":4,"eligibilityCriteria":100,"healthyVolunteers":11,"sex":101,"minAge":18,"maxAge":102,"enrollmentInfo":103,"targetDuration":4,"studyType":23,"phases":105,"briefSummary":106,"conditions":107,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":109,"lastUpdatePostDateStruct":110,"startDateStruct":112,"completionDateStruct":114,"leadSponsor":116,"locationsCount":71},"100530960","effect-of-phaseolus-vulgaris-l-dry-extract-on-the-modulation-of-weight-and-metabolic-parameters-100530960","NCT06193577","Effect of Phaseolus Vulgaris L. Dry Extract on the Modulation of Weight and Metabolic Parameters","Single-centre, Prospective, Randomized, Placebo-controlled, Single-blind Clinical Trial to Evaluate the Efficacy of a Food Supplement Based on Phaseolus Vulgaris L. Dry Extract on the Modulation of Weight and Metabolic Parameters","Inclusion Criteria:\n\n* Male subjects aged between 18 and 60 years\n* BMI between 25 and 35 kg\u002Fm2\n* Habitual consumption of three main meals a day\n* Stable body weight during the 3 months prior to enrollment\n* Commitment to adhere to the diet and avoid the use of other weight loss products during the study\n* Commitment not to change lifestyle significantly for the entire duration of the study.\n* Signing of informed consent\n\nExclusion Criteria:\n\n* Hypergonadotropic hypogonadism and hypogonadotropic hypogonadism\n* Diabetes mellitus\n* Smoking \\> 10 cigarettes\u002Fday\n* Alcohol \\> 2 alcohol units\u002Fday (equal to 24 g of ethanol)\n* History of eating disorders during the 12 months prior to enrollment\n* Use of any drug or product to treat obesity (e.g. meal replacements)\n* Presence of acute or chronic gastrointestinal diseases\n* Active use of drugs that could influence the functions: gastrointestinal (e.g. laxatives, etc.), insulin (insulin sensitizers, etc.) and\u002For testicular (hormones, substances that influece testosterone production\n* Known sensitivity to the ingredients of the preparation\n* Any other clinical condition judged by the investigator to be incompatible with participation in the trial","MALE","60 Years",{"count":104,"type":22},60,[25],"Evaluation of the efficacy of Phaseolus vulgaris L. dry extract on weight modulation.",[108],"Weight Loss","2025-01-07",{"date":111,"type":34},"2025-01-08",{"date":113,"type":34},"2023-11-08",{"date":115,"type":22},"2025-06-30",{"name":40,"class":41},{"id":118,"slug":119,"hasResults":11,"nctId":120,"briefTitle":121,"officialTitle":122,"acronym":4,"eligibilityCriteria":123,"healthyVolunteers":16,"sex":17,"minAge":124,"maxAge":79,"enrollmentInfo":125,"targetDuration":4,"studyType":127,"phases":4,"briefSummary":128,"conditions":129,"keywords":131,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":134,"lastUpdatePostDateStruct":135,"startDateStruct":137,"completionDateStruct":139,"leadSponsor":141,"locationsCount":142},"100571353","evaluation-of-the-safety-and-efficacy-of-profhilo-structura-100571353","NCT06719154","Evaluation of the Safety and Efficacy of Profhilo® Structura","Prospective, Multicentric, Controlled, Double Arm Clinical Investigation to Evaluate the Safety and Efficacy of Profhilo® Structura for Face Adipose Tissue Restoration","Inclusion Criteria:\n\n1. Healthy subjects\n2. Male and Female subjects.\n3. Age : between 35 and 55 year\n4. Subject having given freely and expressly his\u002Fher informed consent obtained according to ISO 14155:2020 and Good Clinical Practice (GCP)\n5. Only for treated group: Subject seeking aesthetic improvement for a corrective\u002Ffilling action of natural and induced skin depressions\n6. Women of childbearing potential must have a negative urine pregnancy test result at inclusion visit and must use a reliable method of contraception since at least 12 weeks and throughout the study.\n7. Subject psychologically able to understand the information related to the investigation including possible risks and side effects.\n8. Subject able to cooperate with the Investigator and to comply with the requirements of the entire investigation (including ability to attend all the planned investigation visits according to the time limits), based on investigator's judgement.\n9. Subject agreeing to keep their usual cleansing \u002F care products during the whole study period.\n10. Subject agreeing to apply a SPF50 cream during the whole study period.\n\nExclusion Criteria:\n\nIn terms of population\n\n1. Pregnant or breastfeeding woman or planning a pregnancy during the study.\n2. Subject who had been deprived of their freedom by administrative or legal decision or who is under guardianship.\n3. Subject in a social or sanitary establishment.\n4. Subject enrolled in another study or whose non-enrollment period is not over.\n5. For France only: subject having received a total of 6.000 euros as compensations for their participation in the present study.\n6. Subject disagrees to keep a stable weight during the study (BMI variation ± 1)\n7. Subject with high expectations for the treatment effect.\n\n   In terms of associated pathology\n8. Subject suffering from a severe or progressive disease or any other pathology that may interfere with the evaluation of the study results and\u002For subject safety\n9. Subject with known history of or suffering from autoimmune disease and\u002For immune deficiency\n10. Subject suffering from active disease such as inflammation, infection, tumour, inflammatory and\u002For infectious cutaneous disorders (herpes, acne, rosacea, porphyria…) in the 6 months before screening visit\n11. Subject with a history of streptococcal disease or an active streptococcus infection\n12. Subject prone to develop inflammatory skin conditions or having tendency to bleeding disorders.\n13. Subject predisposed to keloids or hypertrophic scarring or having healing disorders\n14. Subject having history of severe allergy or anaphylactic shock including known risk of hypersensitivity to one of the components of the composition of the investigational device and to antiseptic solution related to previous or current treatment.\n15. Subjects with scar, mole, hair or local skin infection (including viral, bacterial, and fungal); skin granulomas; scar constitution; immune system disorders; presence of active or progressive skin disorders or skin diseases with isomorphic response in the treatment area, such as acute eczema, flat wart, lichen planus, psoriasis vulgaris, etc…\n16. Patients with psychiatric disorders or emotional instability.\n\n    In terms of previous or ongoing treatment or procedure\n17. Any medication which may interfere, at the interpretation of the investigator, with the study objectives.\n18. Subject having undergone tooth extraction or dental implant procedure within the past 6 weeks or plans to undergo these procedures during the study.\n19. Subject having received facial or cervico-facial lifting in the past 24 months or plans to undergo these procedures during the study.\n20. Subject having received treatment with a laser, ultrasound or radiofrequency treatment, a dermabrasion, a surgery, a chemical peeling or any other procedure based on active dermal response on the face within the past 6 months or who plans to undergo any of these procedures during the study.\n21. Subject having received within the past 18 months or planning to receive during the study any injections outside of those in the study protocol including non-permanent fillers (e.g., HA, Calcium Hydroxyapatite) or autologous fat on or near the face.\n22. Subject having received within the past 9 months or planning to receive during the study any injections outside of those in the study protocol including mesotherapy or botulinum neurotoxin on or near the face.\n23. Subject having received at any time or planning to receive a permanent filler on the face (e.g., polylactic acid, Polymethylmethacrylate, silicone) during the study.\n24. Subject with subcutaneous retaining structure on the face (meshing, threads, gold strand).\n25. Subject having received in the last 24 months resorbable threads lift on the face.\n26. Subject having received at any time injection with unknown products\n27. Subject using medication such as aspirin, high dose Vitamin C, nonsteroidal anti-inflammatory drugs (NSAIDs), antiplatelet agents, thrombolytics or anticoagulants within one week prior to injection visit or being a chronic user.\n28. Subject using medication such as narcotic, and immunosuppressive drugs from three weeks before screening visit and during the whole study period\n29. Subject having started or stopped an antidepressant 3 weeks prior the study or plans to use it during the study.\n30. Subject undergoing a topical treatment on the face or a systemic treatment:\n\n    * anti-inflammatory medication and\u002For antihistamines within the past 2 weeks and during the study,\n    * corticosteroids within the past 2 weeks and during the study,\n    * retinoids and\u002For immunosuppressors within the past 3 months and during the study.\n\n    In terms of lifestyle\n31. Intensive exposure to sunlight or UV-rays within the previous month and\u002For planning to do so during the study.\n32. Heavy smoker (subject who reports smoking 10 or more cigarettes per day);\n33. Subject with an excessive consumption of alcohol (more than 2 glasses of wine per day)","35 Years",{"count":126,"type":22},164,"OBSERVATIONAL","Profhilo® Structura is composed of a buffered saline solution of high molecular weight (H-HA) and low molecular weight (L-HA) hyaluronic acid. The high- and low-molecular-weight HA used in the device is obtained by biofermentation and has not undergone chemical modification processes; this results in excellent tolerability of the product.\n\nIn addition, the HA chains with different molecular weight present in Profhilo® Structura, thanks to a specific and patented treatment of the solution (NAHYCO® Hybrid Technology), interact with each other, giving Profhilo® Structura unique rheological properties that allow higher concentrations of HA to be administered at equal viscosity of the solution.\n\nThe formulation based on HA with different molecular weight contained in Profhilo® Structura is based on the Hydrolift® Action system, the innovative approach aimed at combating the physiological decrease of HA in the skin, restoring hydration, elasticity and tone, synergistically associating deep hydration with the mechanical lifting action of the skin depression.\n\nThanks to its rheological properties and cohesivity Profhilo® Structura is able to optimally spread and integrate into the interstitial spaces of the adipose tissue. Profhilo® Structura has the specific indication for adipose tissue restoration and is able to counteract facial volume loss.",[130],"Skin Aging",[132,133],"aging","adipose tissue","2024-12-02",{"date":136,"type":34},"2024-12-05",{"date":138,"type":34},"2024-09-09",{"date":140,"type":22},"2025-12",{"name":40,"class":41},3,""]